How to Find The Best CER Medical Writers & Strategy
Are you shopping for CER writers? Or perhaps trying to evaluate if this [...]
How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR
A literature review is a formal collection of scientific studies published in peer-reviewed journals [...]
What to Look for in a Clinical Evaluation Report Writer
Writing a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745) [...]
Vigilance: IVDR – A Review of Vigilance Regulations for In Vitro Diagnostic Devices
The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared [...]
IVDR FAQ and Best Practices for The Vigilance of In Vitro Diagnostic Medical Devices
The purpose of vigilance is to protect the health and safety of patients, healthcare professionals, [...]
Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to [...]
The Post-Market Surveillance Document: Which Ones Do you Need?
It's not enough to make a device and put it on the market—you must know [...]
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by [...]
In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so that you can market your [...]
Medical Device Reporting (MDR): How to Report Problems to the FDA
Even though every medical device manufacturer does their utmost to ensure their medical devices are [...]